Wednesday, March 8, 2023

Freestanding birth center bill hits roadblock: Senate floor leader

3/10/23: This story has been updated. 

By Melissa Patrick
Kentucky Health News

Even though a Senate bill to remove the state's certificate of need requirements from freestanding birthing centers has passed out of the same committee twice, most recently in weaker form, and the House version of the bill has cleared a committee, the prospects of it becoming law have dimmed. 

Sen. Damon Thayer
Senate Majority Floor Leader Damon Thayer, R-Georgetown, said at the March 3 Licensing and Occupations Committee meeting that while he appreciated the sponsor's efforts to improve the bill, made at his request, bills regarding certificates of need for health-care facilities "are not moving forward this session." 

Thayer, who calls bills up for a vote on the Senate floor, said "It’s very likely that we’re going to have a task force or a working group or one or two committee meetings dedicated to the certificate of need issue this summer."

Senate Bill 67, sponsored by Sen. Shelley Funke Frommeyer, R-Alexandria, cleared the Licensing and Occupations Committee on Feb. 21 on a 9-2 vote. On March 3, it was recommitted to the same committee, and on March 7 the panel approved an amended version of the bill by a vote of 7-3. 

The "no" votes came from Republican Sens. Amanda Mays Bledsoe of Lexington, Chris McDaniel of Ryland Heights, and Thayer. Sen. Donald Douglas, R-Nicholasville, a physician, passed.

"The committee sub is good and it moves it in the right direction," Thayer said in explaining his vote. "But I think I would be disingenuous knowing that we're probably going to take a deep dive into this issue during the interim. . . . I'm going to vote no because I just don't think it's ready for prime time yet." 

The new version of the bill would only allow freestanding birthing centers that have four or fewer beds to be exempt from having a certificate of need.

"This truly is a concession to the Kentucky Hospital Association," Funke Frommeyer said.

Funke Frommeyer told Kentucky Health News that the changes to the bill that were suggested after it passed the first committee "came straight from the KHA," even though "not once did they reach out to me to talk through their concerns before I brought the bill to committee." 

Freestanding birthing centers only provide vaginal deliveries for women with low-risk pregnancies.  Funke Frommeyer told the committee that Kentucky is one of only eight states that do not offer freestanding birthing centers. 

When asked, Funke Frommeyer wouldn't say the bill was dead. However, she suggested an immediate way forward for freestanding birthing centers in Kentucky is for hospitals to open and run them, like the Vanderbilt model the KHA described in the committee. 

Thayer was not so optimistic when asked if there was any hope for the bill this session.

"It doesn't look good for this session," he said. "It just doesn't have the votes to pass the Senate and it's probably going to go into this entire certificate of need conversation we're going to have during the interim."

Senate Concurrent Resolution 165 to establish the CON Task Force was introduced in the Senate March 10, with 27 sponsors. The resolution calls for all findings and recommendations to be submitted to the Legislative Research Commission by Dec. 1, 2023. 

Kentucky hasn't had a freestanding birthing center since the 1980s, although it has administrative regulations for licensing them and qualifying them for Medicaid reimbursement.

The revisions also added that the Cabinet for Health and Family Services would delineate requirements for medical malpractice insurance for the freestanding birthing centers, refers to the centers as health facilities instead of institutions and adds some screening and reporting requirements. 

Proponents of the birthing centers say the greatest roadblock to these centers is the certificate-of-need law, which require a center to prove that there is an unmet need for services before it can open, which allows providers and hospitals to challenge the would-be competitor's application.   

Several hospital officials spoke against removing the requirement. KHA President Nancy Galvagni argued that the certificate-of-need process is necessary for the health and safety of patients. 

"The proposed legislation and the committee sub to remove freestanding birthing centers from CON would require a change in regulation, removing the requirement for oversight of the facility by an obstetrician with admitting privileges at a local hospital," Galvagni said.

She also noted that the bill does not require a written transfer agreement with a Kentucky hospital. "If a complication during birth arises, a quick transfer from the birthing center to the hospital is going to be critical to the health and life of the mother and child. And without those written transfer agreements in place, a complicated birth could easily lead to the death of the mother, the baby or both," she said. 

Thayer and Committee Chair John Schickel, R-Union, scolded the KHA for not bringing its issues to the committee during the interim between legislative sessions, when the issue was discussed. Galvagni said they did not testify because they thought their position on this bill was "very well known." 

House Bill 129, sponsored by Rep. Jason Nemes, R-Louisville, passed out of the Feb. 22 House Licensing, Occupations & Administrative Regulations Committee without dissent and two pass votes. It has received two of its three required readings but still awaits a vote in the full House.

Nemes told Kentucky Health News that even though the Senate bill had stalled, he was heartened by its movement forward this session, largely because it revealed the opponents objections, which will now allow them to address those concerns.  

"I still feel good about it because we got really long into the process," he said. "If we don't get this resolved this session, we're going to have a strong, strong push over the interim and try to get it done next session."


Tuesday, March 7, 2023

In first gubernatorial debate, Cameron says he could sign a medical-cannabis bill; Keck favors exceptions to abortion law

Candidates who debated, clockwise from upper left:
Somerset Mayor Alan Keck, Attorney General Daniel
Cameron, state Auditor Mike Harmon, Commissioner
of Agriculture Ryan Quarles (Spectrum News image)
By Al Cross
Kentucky Health News

Attorney General Daniel Cameron said Tuesday night that he could sign a medical-marijuana bill as governor if it law-enforcement and medical experts "can get around a framework that is responsible."

Cameron was one of four Republican candidates for governor who appeared in the first debate of the race, held in Louisville by Spectrum News, a cable-television service.

Somerset Mayor Alan Keck separated himself from the other three by saying "there should be some exceptions" to the law that bans abortion except in cases of threat to the woman's life.

When Cameron ran for attorney general four years ago he was "absolutely" against medical marijuana, Nick Storm of Kentucky Fried Politics noted in his post-debate analysis for Spectrum. Then, he was the candidate of law enforcement, but now polls show overwhelming voter support for medical cannabis, Storm noted.

Agriculture Commissioner Ryan Quarles, who came out for medical cannabis a week earlier, said whatever law the state had needs "a very narrow framework." Keck said he "came out with this policy position months ago," and said it is "another example of Kentucky lagging behind. . . . We need to get the Senate on board and get it done.”

The Senate has not taken up medical-cannabis bills that the House, also controlled by Republicans, has passed in two legislative sessions. Late last year, Democratic Gov. Andy Beshear used his pardon power to allow people with a doctor's certification that they have at least one of 21 specified medical conditions to possess up to eight ounces of cannabis bought legally in another state.  

State Auditor Mike Harmon, who answered the question last, said "I'm not there yet, but I am open to discussion."

The debate did not include former United Nations ambassador Kelly Craft, who declined the invitation from Spectrum and the Jefferson County Republican Party, which co-sponsored the event.

On abortion, Cameron, Harmon and Quarles said they support the current law, but Keck said, "I struggle, candidly, with this . . . I'm absolutely pro-life . . . I do believe there should be some exceptions … there has to be consideration for the woman in the event of violent trauma to them, especially in adolescence."

Asked if they would support greater public availability of Narcan, which counteracts drug overdoses, Harmon said he would be. Cameron said local officials should make the decision, and Keck said he is "a big believer in local control." Quarles said he would have to discuss the idea with legislators, law enforcement and people in public health.

Learn how to nominate someone for recognition as a Healthy Kentucky Champion in a 30-minute webinar at noon ET March 21

Mental-health advocate Sheila Schuster, center, was the first Gil Friedell Health
Policy Champion, selected from several Healthy Kentucky Champions, in 2019.
Kentucky has many "Healthy Kentucky Champions," people recognized by the Foundation for a Healthy Kentucky for their efforts to make our state a healthier place. You may know someone worthy of this award, but don't know how to nominate them. Here's your chance to give them the recognition they deserve.

The foundation will host "Health for a Change: Recognizing Healthy Kentucky Champions," a 30-minute webinar, at noon ET Tuesday, March 21. Viewers will learn about the program, its benefits, and how to nominate someone. "You’ll get the inside scoop on how to make your nomination stand out from the bunch," the foundation says in a news release. "Let’s promote the efforts of people working to improve the health of Kentuckians!" To register, click here

Panelists on the webinar will be Ashley Brauer, the foundation's vice president of communications, and Matthew Coleman, a member of its Community Advisory Council and a project manager for the Kentucky Office of Rural Health in the University of Kentucky Center of Excellence in Rural Health.

Monday, March 6, 2023

On the third anniversary of the pandemic's arrival in Ky., the virus continues to infect and kill; state's new-case rate still 3rd in nation

New York Times graphs show panedmic's history in U.S. and states with top three new-case rates.

By Melissa Patrick

Kentucky Health News

Today, March 6, marks the third anniversary of the announcement of Kentucky's first case of Covid-19, a disease that has infected more than 1.7 million Kentuckians and killed 18,130 of them.

And while the Covid-19 national emergency and public-health emergency declarations that have been in place since early 2020 will end May 11 and the state is scaling back its Covid-19 reporting, that doesn't mean Covid-19 is over. Kentuckians are still getting Covid-19 and still dying from it.

The state Department for Public Health's new webpage with Covid-19 surveillance data says there were 4,736 new cases of the coronavirus last week, or 676 cases per day. That's up 44% from last week's report. 

The state attributed 13 more deaths to Covid-19 last week, down from 39 the week prior.

The weekly new-case rate was 7.99 cases per 100,000 residents, down from 9.23 in the prior weekly report. The top 10 counties were Trigg, 25.35 cases per 100,000; Adair, 20.09; Green, 19.59; Rockcastle, 17.97; Lewis, 17.22; Bell, 17.01; Russell, 16.74; Hopkins, 15.03; Bath, 14.86; and Metcalfe, 14.19. 

The New York Times ranks Kentucky's seven-day case rate third among states, even with a 27% decline in cases in the last two weeks. 

The newly formatted state report does not include does not include hospital numbers or positive-test rates. Test numbers have become largely unreliable since they do not include results from at-home testing. 

Reflections on the pandemic

Health Commissioner Steven Stack and Gov. Andy Beshear were asked at the governor's March 2 press conference to reflect on what they think future generations will say when they look back at the pandemic. 

Stack, a physician, said he hopes Kentuckians will remember how everyone pulled together to face this "once in a century" or once-in-a-generation event, and that graphs and charts won't reflect that. 

"Overwhelmingly, we came together and we worked together," Stack said. "It was hard, it was difficult, [it] disrupted our lives, all of those things are undeniable, but we faced it and confronted it together. . . . We were one Kentucky, and I think that's a big deal." 

As for what the charts and graphs will show, Stack said, "People are gonna pore over that for a very, very long time. But I am confident that we managed to flatten that curve at various points in time, that people taking actions that we asked them to take and looking out for their neighbors helped us to keep people alive and to save lives. And so I think when history looks back on this, it'll look back favorably on the four and a half million Kentuckians who all came together to look out for each other and save lives." 

Beshear, who is favored for re-election this year largely on the basis of public approval of his work during the early momths of the pandemic, said he thinks history will show "the most effective battle against a pandemic in human history." 

"Look at how quickly we got vaccines, you look at the initial projections of how many people we'd lose versus the number that we've lost," he said. " I think we will always look at some things and wonder if we could have done this or that a little bit better. But I don't think that negates the fact that this I think has been the most effective battle against a virus that came to kill as many of us as possible."

Sunday, March 5, 2023

Bill would create phone app for confidential mental-health texting for Ky. youth; 9.5% of Ky. high-schoolers have attempted suicide

Photo from Parenting Teens & Tweens
By Melissa Patrick
Kentucky Health News

A bill to create a free mobile-phone application for confidential crisis intervention for Kentucky youth, parents and their teachers is poised to pass the House and go to the Senate Tuesday, March 7. 

"This is really dynamic, and I think pretty much of a needle mover when it comes to helping our kids out when they come across a very significant crisis situation," Rep. Ken Fleming, R-Louisville, told the House Health Services committee before it approved the bill March 2. It passed without dissent, so it was put on the consent calendar, for non-controversial bills that are passes as a group. 

The need for this service is great. In December 2021, the U.S. Surgeon General sounded an alarm about youth mental health by issuing a 53-page health advisory, and the 2021 Kentucky Youth Risk Behavior Survey found that 19% of Kentucky's high-school students seriously considered attempting suicide in the 12 months prior to the survey, 15% of them had made a plan about how they would attempt it, and 9.5% of them actually attempted it. 

The survey also found that 39.2% of the state's high school students said they felt sad or hopeless almost every day for two weeks or more in a row, such that the stopped doing some of their usual activities. 

The 2021 survey asked the state's middle schoolers if their mental health was most of the time or always not good, including stress, anxiety and depression, during the 30 days before the survey and found that 21.9% responded that it was. 

House Bill 196, sponsored by Fleming, would establish the Kentucky Mental Health Protection Center within the UofL Health hospital system to create and maintain the mental-health app. The program is modeled after a similar program in Utah and would be called SafeKY. The app will be available to all students, parents, and teachers.

Fleming said the plan is to do a pilot project with the app in the next year and then offer it statewide.

Liz McCune, vice president and chief operations officer at UofL Health, emphasized that the SafeKY phone app will connect youth with a licensed counselor via text, which she said is the preferred form of communication among young people. She said 89 percent of teens carry a cell phone. 

She said text conversations would be anonymous, but the licensed provider can connect the texter with law enforcement, school officials, a trusted adult or a parent "so that they can help in resolving the crisis situation." In addition to mental-health crisis, the app can also be used by students, parents and school officials if they become aware that a student has a weapon on campus.

"This is meant to be an extension of school personnel and an extension of emergency services in getting these kids connected in order to prevent any major catastrophic event," McCune said.

She said the Utah program "that we've been working with handles about 32,000 inquiries a year in which they have worked to reduce acts of suicide, as well as become aware of weapons and hopefully present prevented any catastrophic events." 

Fleming called the bill "monumental" and said the bill is "very important for the life of our kids," noting that many of the Utah texts have come in between 11 p.m. and 3 a.m.

Fleming said the SafeKY program would complement 988, the new, easy-to-remember suicide and crisis lifeline that is available nationwide.

McCune said  988 representatives in the state told her that Kentucky has 10 call centers that answer 988 calls but only one or two of them can take texts. SafeKy is designed to primarily be a text-and-chat app, and if needed, would be able to loop into 988 or 911 services.

Bill to leave children's Covid-19 vaccination decisions entirely with parents and guardians is approved by a House committee

By Melissa Patrick
Kentucky Health News

Kentucky lawmakers have sent the House a bill to ensure that the state's children are not required to get a Covid-19 vaccine and that this decision is the responsibility of the child's parents and guardians.

The bill is designed to keep the Kentucky Department of Education from imposing the requirement by regulation, the bill's sponsor told the March 2 House Health Services committee.  

“What my fear is,” said Rep. Shawn McPherson, R-Scottsville, “is if we don’t decide that the parents or guardian is the one responsible for these children to receive Covid shots, then possibly when we get out of session, the KDE could recommend based on CDC recommendations that before kids go back to school next fall, they have to have a Covid shot.”

Kentucky Department for Public Health graph
Fewer than half of Kentucky's school-aged children are fully vaccinated against Covid-19 and this rate decreases with age. The state Department for Public Health's latest weekly report said 17 percent of the 3,289 new coronavirus cases in Kentucky were in people 18 and younger. 

The committee approved a revised bill that expanded the groups that cannot require a child to get the Covid-19 vaccination from the original bill, which only involved the education department. 

It says: "No person, entity, corporation, company, organization, or government agency, public or private, shall require or coerce in any manner any child to receive a vaccination for Covid-19 or any mutated strain of the Covid-19 virus, other than the child's parents, de facto or legal custodians or guardians." 

Rep. Rachel Roarx, D-Louisville, said she opposed the bill because government officials have a "social responsibility" to make sure people in public spaces are vaccinated against contagious diseaes.

"It's of utmost importance for us to ensure that folks are vaccinated for public-health reasons. . . . For a long time in terms of public settings and public schools, we have required vaccinations, and there are alternatives if a family member does not wish to vaccinate, that's why we have homeschool," she said. 

The committee chair, Rep. Kim Moser, R- Taylor Mill, said this bill is about parental choice.

"This in no way diminishes the value of vaccines, this just gives parents a choice in K-12 on for this specific vaccine," she said. "This is being treated much like the flu vaccine, where the variant is different every season . . . That's why we felt like it was important to give parents a choice and not mandate this." 

The committee approved the bill 14-3, with Roarx and fellow Democrats Lamin Swann of Lexington and Roarx and Lisa Willner of Louisville voting no.

House Bill 101 has received two of its three required readings and is posted for passage on the House floor Tuesday, March 7.

Saturday, March 4, 2023

Bill to exclude fentanyl test strips from legal definition of drug paraphernalia awaits initial passage by the Kentucky House

Image from Centers for Disease Control and Prevention
By Sarah Ladd
Kentucky Lantern

Fentanyl test strips would no longer be considered drug paraphernalia in Kentucky under a bipartisan bill that the House Judiciary Committee approved Wednesday, on a 17-0 vote with three passes.

A revised version of House Bill 353, sponsored by Reps. Kim Moser, R-Taylor Mill, and Rachel Roberts, D-Newport, is posted for passage by the full House.

It says “Narcotic drug testing products utilized in determining whether a controlled substance contains a synthetic opioid or its analogues shall not be deemed drug paraphernalia under this section,” unless the prioduct “is utilized in conjunction with the importation, manufacture, or selling of fentanyl or a fentanyl analogue.” It also says any such product with “residual or trace amounts of a synthetic opioid or an analogue thereof shall not be prosecuted as possession of a controlled substance.”

The Centers for Disease Control and Prevention says fentanyl test strips that can detect the presence of fentanyl in pills and other drugs within minutes, and thus help prevent overdoses.

But treating them as drug paraphernalia has dissuaded public agencies and groups that work with drug users from purchasing and distributing them, for fear that doing so would land them in legal trouble, says Kentucky Smart on Crime, a coalition working for justice reforms that address inequities and improve public health. Possession of drug paraphernalia in Kentucky is a class A misdemeanor, punishable by up to a year in jail and $500 fine.

Drug dealers mix fentanyl with other drugs, such as heroin, cocaine, methamphetamine and MDMA, because it takes very little fentanyl to produce a high, making it a cheaper option, says the National Institute on Drug Abuse. The risk of overdose increases when people don’t realize they’re taking fentanyl.

“Test strips and a strong education campaign are evidenced-based practices that can help stem the tide of deaths by fentanyl,” Jennifer Hancock, president and CEO of Volunteers of America Mid-states, said in support of the bill. “We can’t put people on the road to recovery if they’re dead.”

VOA noted that fentanyl played a role in 73% of the 2,250 overdose fatalities Kentucky recorded in 2021, the last year for which a total is available.The state has one of the nation’s worst rates of fatal overdoses.

Other steps people can take to lower overdose risk, according to the CDC, are:
  • Keep Narcan handy.
  • Do not mix drugs.
  • Don’t take drugs alone.
  • Find a treatment center near you at https://findtreatment.gov or call 800-662-4357.

Friday, March 3, 2023

House health chair says anti-trans bill will worsen state's health-workforce shortage, chill doctors' dealings with young patients

Rep. Kim Moser voiced "grave concerns"
about House Bill 470. (Legislative photo)  
By Melissa Patrick
Kentucky Health News

A bill to ban gender-affirming treatment for Kentucky minors would worsen the state's health-care workforce shortage and chill family health providers who often are the first to provide mental health care for children, the chair of the House health committee said as the bill went to the Senate on a 75-22 vote Thursday.

"This proposal undermines everything that we're doing to increase our health-care workforce," Rep. Kim Moser, a Republican from Taylor Mill, told her colleagues. She told Kentucky Health News, "I just don't think that we should be in the business of legislating medical treatment."

Moser was one of three Republicans opposing House Bill 470, sponsored by Rep. Jennifer Decker, R-Waddy (Shelby County). The other opponents were Kim Banta of Fort Mitchell and Stephanie Dietz of Edgewood, also in Northern Kentucky.

Moser, a nurse by profession, warned against the bill's greatly extended 30-year window for lawsuits against a health-care provider who provides any gender-affirming care to a minor, including treatments that support gender transition. Currently, malpractice suits must be filed within one year.

"I just think that we're sending the wrong message in saying that on one hand, we value our health-care workers and we're working on legislation to improve our health-care workers situation, but on the other hand, we're imposing a 30-year statute of limitations," she said. "That sends a huge message to our health-care workers that we are going to micromanage you, we are going to insert government into the practice of medicine, and we are going to punish you if you step out of line." 

A bit earlier, as the House Judiciary Committee approved the bill 14-7, Moser said she appreciated that its latest version removed a defined list of mental-health providers from the list of providers who couldn't treat youth seeking gender-affirming care, but she said the reality is that initial mental health care often falls to a physician, physician assistant or advanced practice registered nurse, and this bill restricts what they can talk about with transgender youth.

"Eighty percent of what family practitioners and many other physicians do in their practice is address mental health," she told the House. "It's not only counselors who address mental health of their patients. Patients come in with a wide variety of situations, and their physicians need to be those trusted individuals with whom they can have a confidential conversation. . . . I think this goes too far. I think it's discriminatory. I think it eliminates parents' rights."

Dr. Craig Losekamp, a Bowling Green physician, told the committee that the bill would impair his practice, because much of his transgender care involves non-transgender-related subjects. He said his patients come from as far as 120 miles away to seek care from him. 

“If this bill goes through, I won’t be able to take care of those kids, talking about those subjects that are very important to them," he said. "It doesn't even involve hormones, it means me acknowledging them and their gender identity and treating them as a compassionate human being."

Losekamp said 10 percent of children who come out to their family suffer physical violence from the family, about 8% are kicked out of their home, 10% run away, and the suicide-attempt rate for transgender people is 40%.

“These people need care, They need their respect. They need to be treated like human beings," he said. 

Later, the committee heard from a trans person who said they were "severely harmed" by a transition gided by their parents. Losekamp said regret happens with all surgeries, but the regret rate for transgender surgery is 1% while the overall rate for all surgeries is one in seven, or 14%.

“If you are going to make a bill pass that will protect that small percentage at the expense of the overwhelming majority, you are not managing harm; you are creating more harm," he said. The bill says it "may be cited as the Do No Harm Act," parroting the most-often cited part of the Hippocratic Oath.

Moser told Kentucky Health News that some have argued that if health-care providers don't break this law, it won't affect them, but she said it bill will cause a "chilling effect" in how they care for their patients, and "I don't think that it gives health-care workers who are looking to relocate or stay in Kentucky and practice medicine any comfort."

Asked why a bill dealing with a health issue wasn't assigned to her committee, Moser said she wasn't consulted about that.

In her closing remarks on the floor, she said, "I'd like to say to the rest of the world who's watching Kentucky, we are not complete Neanderthals; we are generally very thoughtful people."  

Asked later what she meant by that, she said, "I think that we should be a little more responsible in how we are treating children and families and health-care workers. . . . I think that there are [other] ways to address the problem they are trying to solve." 

She suggested that the bill be simplified to say that children under the age of 18 could not have transgender surgery, and to limit hormone therapy to those who have had extensive counseling.

Dr. Chris Bowling, a pediatrician from Northern Kentucky representing the Kentucky Medical Association and the American Academy of Pediatrics, told the committee that gender-affirming care is also supported by: the American College of Obstetrics and Gynecology, the Society for Adolescent Health and Medicine, the Pediatric Endocrine Society, the National Adult Endocrine Society, the American College of Physicians, the World Professional Association for Transgender Health, the American Psychological Association, and the American Academy of Child and Adolescent Psychiatry

“These are not things that should be decided on the basis of feelings; they should be decided on the basis of facts," Rebecca Blankenship, executive director of Ban Conversion Therapy Kentucky, told the committee.  

The panel then heard from supporters of the bill, including three physicians, two who spoke remotely. Two said that left alone, 80% to 90% of these youth will return to their biological gender after the onset of puberty, another cited a long-term study from Sweden that showed damage to children's mental health, and the third noted that a person's brain is not fully developed until the age of 25. 

Luka Hein, 21, who transitioned from female to male as a teenager, but has since detransitioned, said the medical system was not interested in treating the underlying cause of her distress, but instead, she got drugs and surgery and was put in “the pipeline that is the gender-affirming care industry,” which is “experimental.”

Rep. Jennifer Decker, R-Waddy, filed the bill. (Legislative photo)
Rep. Pamela Stevenson of Louisville asked Decker why the government was trying to become the parent to all of these children. Decker replied, "I have great compassion for the children, parents and their families who are in this situation. However, ultimately, it is our obligation to protect children from irreparable harm . . . We do not allow parents to give their children alcohol until the age of 18," nor cigarettes. 

Stevenson, the Democrat running for attorney general, said, "It's not for irreparable harm; it's because they're not like you." 

A new Mason-Dixon poll released by the Fairness Campaign, a pro-LGBTQ rights advocacy group, showed that 71% of respondents oppose laws letting state leaders overrule parents' wishes for gender-affirming care for their child. The Louisville Courier Journal reports that the poll surveyed 625 people with an error margin of plus or minus 4 percentage points.

A study revives debate on masks: Twitter explodes, public is 'befuddled;' prevention may depend on how they're worn

To be effective, masks need to be worn correctly. (Jacek Poblocki, Unsplash)
Haven't the questions about masking been asked and answered? "Or at least that we had all agreed to disagree, but no such luck," writes Felice J. Freyer of The Boston Globe. "The debate over whether masks limit Covid-19 transmission recently reignited after a new review of the research came out, drawing out skeptics and defenders, and — as so often happens — leaving the ordinary citizen befuddled."

How did this get started
 — again? "A British outfit known as the Cochrane Library put out a new report on masking. When the Cochrane Review, which is highly respected in medical circles, tackled the mask question, it found that "wearing a mask may make little to no difference in how many people caught a flu‐like illness/Covid‐like illness," Freyer writes. "But the review encompassed primarily studies conducted before the pandemic, which examined the spread of influenza. The flu is far less contagious than Covid-19, which could lead to underestimating the effects of masks. The review also mixed studies of health-care workers with those involving the general public, and included studies that couldn’t answer the question of whether people actually wore their masks correctly."

Who's causing the fuss? "Twitter erupted with criticisms. Then one of the Cochrane Review authors was quoted in a Substack newsletter article saying of masks, "There is just no evidence that they make any difference. Full stop." . . . The Substack interview prompted New York Times columnist Bret Stephens to scold all those who favored mask mandates, saying they owed the world an apology. That unleashed another round of social media outrage. . . . But as others have pointed out, there’s no evidence that masks don’t make a difference. The big problem is that there isn’t enough evidence, period."

Wait a minute; what do masks prevent? “We have good evidence from laboratory studies [that] if you’re wearing a mask correctly and you’re in the presence of the virus, the mask will protect you,” Jennifer Nuzzo, professor of epidemiology at Brown University School of Public Health, told Freyer. Commenting on the Cochrane Review, Freyer added, “The appropriate conclusion is, we don’t have great evidence showing that masks change infection rates in populations. But we don’t know why that is. It’s probably not to do with masks themselves, but how they’re worn.”

What did Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, say about the Cochrane study? “It’s a meta-analysis of a very large number of studies, many of which had nothing to do with Covid, and many of which did studies with masks that were not regularly worn every day and properly,” Fauci told Freyer. “There were only two studies in that entire meta-analysis that were exclusively looking at masks with Covid.”

Could I get a straight answer? "The basic advice hasn’t changed. Wear a mask in situations where you think you’re at risk of infection, such as a crowded indoor setting, especially during a time when Covid transmission is high," Freyer reports. "The level of that risk is determined by the level of transmission in your community, your own vulnerability to severe illness, the vulnerability of people you expect to come in contact with, and your personal tolerance for risk."

Final thoughts? Fauci told Freyer, “Everyone is different. Everyone’s risk for a complication is different. So there’s no set rule.”

Thursday, March 2, 2023

CDC says no Ky. counties at high risk of Covid-19; state planning moves to adapt to May 11 end of federal public-health emergency

Centers for Disease Control and Prevention maps
By Melissa Patrick
Kentucky Health News

No Kentucky counties have a high risk of Covid-19, according to this week's Centers for Disease Control and Prevention's weekly risk map, and only 30 of the 120 counties are at medium risk.

The CDC map, which is based on the number of new coronavirus cases and Covid-19 patients in Kentucky hospitals, shows 90 counties have a low level of infection, shown in green. The 30 with a medium level of infection, shown in yellow, are largely in the western and Appalachian areas of the state. 

In counties at medium risk, the CDC advises those who are at high risk of getting very sick to wear a well-fitting mask when indoors and in public and to consider getting tested before having social contact with someone at high risk for getting very sick and consider wearing a mask when indoors when you are with them.

The CDC also provides a community transmission level map, largely used by researchers and health-care facilities, that shows the level of virus in each county, at one of four levels. The map shows Magoffin County with a low level of transmission, 28 counties with moderate levels and the rest with either substantial or high levels, showing that the virus continues to be widespread in those counties.

As of Thursday, March 2, The New York Times ranked Kentucky's infection rate over the previous seven days as third in the nation, despite a 27 percent drop in cases in the last two weeks. 

State to scale back Covid-19 measures 

Looking to the end of the national Covid-19 public-health emergency on May 11, state Health Commissioner Steven Stack said at Gov. Andy Beshear's weekly news conference Thursday that the state will no longer have the same access to Covid-19 therapeutics to distribute or dispense, and its dedicated Covid-19 hotline will end on May 12.

Stack said Covid-19 surveillance in Kentucky will continue, but will probably evolve into a fall/winter respiratory report that includes Covid-19, influenza and RSV (respiratory syncytial virus). 
This change will provide "a more comprehensive look at the most common infections that typically cause problems for health care capacity," said Stack, who is a physician. 

There will be changes in what states are required to report regarding Covid-19, and that will alter the data available, Stack said. And while hospitals will still be required to report Covid-19 data for another year, Stack said the frequency of that reporting will likely change.  

He said the state's Covid-19 website will continue, but will be more streamlined. These changes will begin on Monday, March 6, when the state will move all its Covid-19 data to one site and remove any duplicate reporting. He said the site will keep providing educational information, but much will be linked directly to CDC information.

Comer says his panel will investigate pharmacy benefit managers

Rep. James Comer chairs the Oversight Committee.
As chair of the House Oversight and Accountability Committee, Republican U.S. Rep. James Comer of Kentucky's First District is launching an investigation into pharmacy benefit managers and how they affect health-care costs. 

PBMs manage prescription-drug benefits for public and commercial insurers, acting as middlemen between them and drug companies. Comer said PBMs drive up drug prices, an assertion the industry disputes.

Comer, R-Frankfort and Tompkinsville, is asking the three largest PBMs, CVS Caremark, Express Scripts and OptumRx, to provide "documents, communications, and information related to their practices that are distorting the pharmaceutical market and limiting high-quality care for patients" by March 15.

When The Washington Post asked the companies for comment, they handed off to the Pharmaceutical Care Management Association, their main lobby. It issued a statement saying, “While we appreciate — and share — the committee’s concern around drug pricing and existing gaps in affordability, we strongly urge members of the committee and Congress to stay focused on real solutions that are proven to reduce prescription-drug costs.” It said they “have a proven track record of reducing prescription-drug costs in federal programs.”

Comer is also seeking information from the Office of Personnel Management, the Centers for Medicare and Medicaid Services and the Defense Health Agency to determine PBMs’ impact on federal health-care programs.

One of Comer's political allies, state Sen. Max Wise, R-Campbellsville, until recently led efforts in the state legislature to more tightly regulate PBMs.

Wednesday, March 1, 2023

Lilly says it will cut prices of 2 old insulin products 70% this year, and immediately cap the cost of another one at $25 per vial

Eli Lilly & Co. announced Wednesday that it will cut the prices of some of its older insulin products this year "and immediately expand a cap on costs insured patients pay to fill prescriptions," The Associated Press reports.

That will provide "critical relief to some people with diabetes who can face annual costs of more than $1,000 for insulin they need in order to live," AP's Tom Murphy writes. "Lilly’s changes also come as lawmakers and patient advocates pressure drugmakers to do something about soaring prices."

Lilly said it will cut by 70 percent the list prices for its most-prescribed insulin, Humalog, and for another one, Humulin, in the fourth quarter of the year, which starts in September. "The drugmaker didn’t detail what the new prices would be," Murphy notes. "List prices are what a drugmaker initially sets for a product and what people who have no insurance or plans with high deductibles are sometimes stuck paying."

Stacie Dusetzina, a health policy professor at Vanderbilt University who studies drug costs, told Murphy that the changes probably won’t affect Indianapolis-based Lilly much financially because the two insulins already have competition.

The authorized generic version of another Lilly insulin, Humalog, will be cut to $25 a vial starting in May. "The cost of a prescription for generic Humalog ranges between $44 and close to $100 on the website GoodRx," Murphy notes.

Lilly's Indianapolis headquarters (Photo by Darron Cummings, AP)
Lilly CEO David Ricks said in a press release that it will take some time for insurers and the pharmacy system to implement the price cuts, so the company will immediately cap monthly out-of-pocket costs at $35 for people who are not covered by Medicare’s prescription-drug program. It said the cap applies to people with commercial coverage and at most retail pharmacies.

Medicare started applying that cap in January, as part of recent legislation.

"Aside from Eli Lilly and the French drugmaker Sanofi, other insulin makers include the Danish pharmaceutical company Novo Nordisk," Murphy reports. "Lilly also is launching in April a biosimilar insulin to compete with Sanofi’s Lantus."

Insulin is an essential hormone that converts food into energy. "People who have diabetes don’t produce enough insulin," Murphy notes. "People with Type 1 diabetes must take insulin every day to survive. More than 8 million Americans use insulin, according to the American Diabetes Association. Research has shown that prices for insulin have more than tripled in the last two decades, and pressure is growing on drugmakers to slow the increases."

Drug manufacturer may be seeing “the writing on the wall that high prices can’t persist forever,” said Larry Levitt, an executive vice president with the nonprofit Kaiser Family Foundation, which studies health care, told Murphy. “Lilly is trying to get out ahead of the issue and look to the public like the good guy.”

Lilly was the first company to commercialize insulin in 1923, "two years after University of Toronto scientists discovered it," Murphy notes. "The drugmaker then built its reputation around producing insulin even as it branched into cancer treatments, antipsychotics and other drugs."